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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807232
Other study ID # ARDS in Burn Patients USZ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 26, 2010
Est. completion date May 23, 2013

Study information

Verified date January 2019
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.


Description:

Rationale:

Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.

Objectives:

To characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.

Methods:

A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date May 23, 2013
Est. primary completion date May 23, 2013
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria:

all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.

Exclusion Criteria:

Exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of post-burn ARDS Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich 6 years
Primary Clinical course of post-burn-ARDS various clinical parameters related to the Outcome of post-burn-ARDS 6 years
Primary predictors of post-burn ARDS To identify relevant predictors of post-burn ARDS, including the development of a prognostic score 6 years
Secondary to examine outcome parameter mortality A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich 6 years
Secondary to examine outcome parameter hospital stay A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich 6 years
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